Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement of Intestinal Inflammation Assessed by Endoscopic Scoring System
研究概览
简要总结
This project involves the use of oral Lactobacillus reuteri as an adjunct therapy for 8 weeks. Endoscopic observation of intestinal inflammation will be conducted at 1 month, 3 months, 6 months, and 12 months after the administration of the drug. Intestinal fluid will be collected endoscopically for 16S RNA analysis to assess changes in the gut microbiota. Inflammatory changes in the patients will be detected through peripheral blood tests, and fecal calprotectin levels will be measured to evaluate the progression of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be over 18 years old
- •Agree to sign informed consent; Have been diagnosed with IBD for at least 3 months but not more than 3 years -
排除标准
- •Does not meet the diagnostic criteria of CD
- •Patients with other autoimmune diseases, infectious diseases and malignant tumors Patients with CD during pregnancy and lactation; Patients with serious diseases of the liver, kidney, heart and lung, etc
- •Patients with allergic diseases such as asthma and allergic rhinitis; alcoholic Patients with mental illness
- •Patients with suspected cancer in their intestines
- •Antibiotics, probiotics and prebiotics have been used in the past three months Had intestinal surgery (except appendicitis surgery)
- •There is currently an infection
- •He has had cancer in the last 5 years -
研究组 & 干预措施
Placebo
Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.
干预措施: Maltodextrin (Dietary Supplement)
Probiotic
Daily intervention with Limosilactobacillus reuteri LR08 (10 billion CFU, 2g) for 8 weeks, stored in a cool and dry place.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Improvement of Intestinal Inflammation Assessed by Endoscopic Scoring System
时间窗: 12 months
The intestinal inflammation will be assessed using the Endoscopic Scoring System, which will be observed under endoscope at 1 month, 3 months, 6 months, and 12 months after the administration of the drug.
次要结局
- Assessment of Intestinal Flora Changes Using 16S RNA Analysis(8 weeks)
- Assessment of Inflammatory Changes Using Peripheral Blood Inflammatory Markers(8 weeks)
- Disease progression(8 weeks)
- Evaluation of Crohn's Disease Severity Using the Crohn's Disease Activity Index (CDAI)(8 weeks)